BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 250538 · Received November 16, 1999

    Report

    Report Number
    1527736-1999-05896
    Event Type
    Malfunction
    Date Received
    November 16, 1999
    Date of Event
    October 21, 1999
    Report Date
    October 21, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT THE ER320 INSTRUMENT CLIPS REMAIN OPEN BETWEEN THE JAWS OF THE DEVICE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA M4EW1C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other